UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037828
Receipt number R000043128
Scientific Title Effect of the test food on sleep and fatigue - A randomized, double blinded, parallel group comparison study -
Date of disclosure of the study information 2019/08/31
Last modified on 2019/08/28 10:38:49

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Basic information

Public title

Effect of the test food on sleep and fatigue - A randomized, double blinded, parallel group comparison study -

Acronym

Effect of the test food on sleep and fatigue

Scientific Title

Effect of the test food on sleep and fatigue - A randomized, double blinded, parallel group comparison study -

Scientific Title:Acronym

Effect of the test food on sleep and fatigue

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of the test food on sleep and fatigue after 4 weeks of ingestion.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

OSA-MA, fatigue VAS scores

Key secondary outcomes

AIS, PSQI-j, JESS, SMH, POMS2-AS scores, serum DHEA-S, serum cortisol, the ratio of serum DHEA-S and serum cortisol


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of test food 1 and placebo 1 for 4 weeks.

Interventions/Control_2

Intake of test food 2 and placebo 2 for 4 weeks.

Interventions/Control_3

Intake of test food 3 and placebo 2 for 4 weeks.

Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

30 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

1.Participant who works on the week days (Monday through Friday).
2.Participant who has regular working days and non- working days (one must have at least 2 consecutive non-working days).
3.Participant whose T score of the Fatigue-Inertia for POMS2 is above 49, and T score of the Vigor-Activity for POMS2 is less than 51 at the pre-test.
4.Participant whose score for Athens Insomnia Scale is above 5.

Key exclusion criteria

1.Subject who is under medication treatment, dietetic therapy, or exercise therapy
2.Subject who is under sleep, stress, and/or fatigue treatment
3.Subject who has or has a history of diabetes, liver disease, kidney disease, heart disease, having troubles in adrenocortical hormone secretion, or other metabolic disease
4.Subject who has history of mental illness, chronic fatigue syndrome or sleep disturbance
5.Subject who has been diagnosed as or who is suspected as sleep apnea syndrome
6.Subject who is taking regular medication, or who has or had a history of serious disease that requires regular medication
7.Subject who is regularly taking medication, quasi-medicine, health food or food with functional claims that affect the test results
8.Subject who is a day shift worker or is involved in manual labor such as heavy object transportation
9.Subject whose working days and non-working days are irregular
10.Subject who is planning to work on more than 2 night shifts during the study period
11.Subject who showed abnormal clinical test results or cardiopulmonary function and has been decided as an inappropriate candidate for the present study
12.Subject who has an allergy for the test food
13.Subject who is currently pregnant or planning to get pregnant and breast feed the baby during the study period
14.Subject who has participated in other clinical studies within the last one months
15.Subject who cannot follow the regulations of the current study and cannot carry out the specified questionnaires
16.Subject who is decided as an inappropriate candidate according to the life style habit questionnaire
17.Subject who showed abnormal physical examination value and other clinical test values
18.Subject who is planning to go abroad during the study period, or is planning to go for a domestic travel for more than 7 consecutive days
19.Subject who is considered as an inappropriate candidate by the doctor in charge or the lead principal investigator

Target sample size

90


Research contact person

Name of lead principal investigator

1st name Kei
Middle name
Last name Yui

Organization

FANCL Corporation

Division name

Research Institute, Health science research center

Zip code

244-0806

Address

12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa

TEL

045-820-3755

Email

ke-yui@fancl.co.jp


Public contact

Name of contact person

1st name Hiroyasu
Middle name
Last name Shimada

Organization

TTC Co., Ltd.

Division name

Clinical Research Planning Department

Zip code

150-0021

Address

1-20-2, Ebisu-nishi, Shibuya-ku, Tokyo, Japan

TEL

03-5459-5329

Homepage URL


Email

h.shimada@ttc-tokyo.co.jp


Sponsor or person

Institute

TTC Co.,Ltd.

Institute

Department

Personal name



Funding Source

Organization

FANCL Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Aisei Hospital Ueno Clinic Research Ethics Committee

Address

2-18-6, Higashiueno, Taitou-ku, Tokyo

Tel

03-6455-0880

Email

t.saito@ttc-smo.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

公益財団法人愛世会 愛誠病院 上野クリニック


Other administrative information

Date of disclosure of the study information

2019 Year 08 Month 31 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

0

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2019 Year 09 Month 22 Day

Date of IRB

2019 Year 08 Month 23 Day

Anticipated trial start date

2019 Year 10 Month 01 Day

Last follow-up date

2019 Year 11 Month 10 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 08 Month 28 Day

Last modified on

2019 Year 08 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043128


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name